FDA"s Frances Kelsey Questions Thalidomide Safety in 1960s U.S
- Frances Oldham Kelsey, an FDA medical examiner, was tasked with evaluating the safety of thalidomide, known as Kevadon in the U.S.
- Despite pressure from the drug's distributor, Kelsey insisted on obtaining more information before allowing its market release.
- Her thorough investigation ultimately revealed significant safety concerns, preventing potential harm to the public.
In the early 1960s, the drug thalidomide, marketed in the U.S. as Kevadon, faced scrutiny from Frances Oldham Kelsey, an FDA medical examiner. Despite pressure from the drug's distributor to expedite its market release, Kelsey insisted on thorough safety evaluations. Her diligence was fueled by concerns over incomplete information regarding the drug's safety, which had been highlighted in communications from medical professionals. As Kelsey continued her investigation, she received various pill samples from pharmaceutical companies, maintaining her medical license to assess their contents. This routine practice allowed her to stay informed about potential risks associated with new medications. Meanwhile, alarming reports about thalidomide's effects began to surface, raising questions about its safety and the lack of awareness regarding its dangers. The situation escalated when urgent letters were exchanged between medical professionals and the drug's British distributor, indicating a growing concern over the drug's safety profile. Kelsey’s persistence in seeking evidence ultimately led to a deeper understanding of the drug's risks, which had been overlooked for years. The culmination of Kelsey’s efforts resulted in a significant public health revelation, highlighting the importance of rigorous drug safety evaluations. Her work not only prevented potential harm to countless individuals but also underscored the critical role of regulatory oversight in the pharmaceutical industry.